FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE
K Number: K833708
·
Decision Jan 4, 1984
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
19
Review Days
76
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Basic Information
- Device Name
- COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE
- K Number
- K833708
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7100
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Worthington Diagnostic Systems
- Date Received
- October 20, 1983
- Decision Date
- January 4, 1984
- Product Code
- LKZ
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LKZ | Red-Cell Count By Photometry | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LKZ), ordered by most recent decision date.
View allOther Clearances by Worthington Diagnostic Systems
| K Number | Device Name | ||
|---|---|---|---|
| K832748 | COMPUR* EASYTOUCH TOTAL BILIRUBIN | Oct 14, 1983 | Substantially Equivalent |
| K832427 | EASYTOUCH TROMBOPLASTIN REAGENT | Oct 14, 1983 | Substantially Equivalent |
| K832785 | COMPUR* EASY TOUCH URIC ACID REAGENT | Oct 14, 1983 | Substantially Equivalent |
| K832749 | EASYTOUCH BUN REAGENT SET | Oct 14, 1983 | Substantially Equivalent |
| K832750 | EASYTOUCH HEMOGLOBIN REAGENT | Sep 26, 1983 | Substantially Equivalent |
| K832426 | EASYTOUCH TRIGLYCERIDES REAGENT SET | Sep 12, 1983 | Substantially Equivalent |
| K831477 | DEMAND ANALYZER SYSTEM | Jun 17, 1983 | Substantially Equivalent |
| K831318 | COMPUR* M1100 HEMATRCRIT SYSTEM | Jun 8, 1983 | Substantially Equivalent |
| K831227 | COMPUR EASY TOUCH CHEMISTRY ANALYZER- | Jun 2, 1983 | Substantially Equivalent |
| K831102 | TIA-IGA REAGENT & CALIBRATOR SETS | Apr 27, 1983 | Substantially Equivalent |